What side effects are associated with this type of intervention?

Common treatments for obesity, particularly GLP-1 receptor agonists like Semaglutide, often have side effects including gastrointestinal symptoms such as nausea, vomiting, and diarrhea. There is also a potential risk of acute pancreatitis and, in rodent studies, an association with benign and malignant thyroid C cell tumors. However, the relevance of these findings to humans is unclear, and these medications are generally not recommended for individuals with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia. Other side effects may include injection site reactions and, less commonly, hypoglycemia when used in combination with other glucose-lowering agents.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Semaglutide, a GLP-1 receptor agonist, has been approved for weight loss in individuals with obesity or overweight with weight-related comorbidities. Other similar drugs include liraglutide, which was approved for weight management in adults and adolescents with obesity. These medications work by promoting weight loss through appetite suppression and improved glycemic control.

What other types of research exist?

Promising alternatives to Semaglutide for obesity treatment in 2024 include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown superior weight loss in clinical trials compared to Semaglutide. 2) Liraglutide, another GLP-1 receptor agonist, which is already approved for weight management and has demonstrated efficacy in reducing body weight. 3) Emerging therapies such as Setmelanotide, a melanocortin 4 receptor (MC4R) agonist, which is being investigated for obesity treatment in patients with specific genetic conditions. These alternatives offer different mechanisms of action and have shown promising results in clinical studies.

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Glucagon-like peptide-1 receptor agonist

Semaglutide for Obesity (STABLE Wt Loss Trial)

Phase 4

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-70 years

Be older than 18 years old

Must not have

A diagnosis of type I or II diabetes

Clinically significant hepatic (i.e., liver fibrosis, cirrhosis or confirmed NASH) or renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up s1: change from baseline to weeks 20, 40, and 60, and measures at week 72; s2: week 72 endpoint controlling for s1 baseline

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study the effects of semaglutide, a weight-loss medication, on eating behavior and appetite. All participants will receive diet and exercise counseling, and will be prescribed semaglutide or placebo for 72 weeks.

Who is the study for?

Adults aged 18-70 wanting to lose weight, with a BMI ≥ 30 or ≥ 27 with obesity-related health issues. Must not be pregnant, able to consent, and plan to stay in Philadelphia for the study duration. Excludes those with uncontrolled diabetes or hypertension, recent pancreatitis or cancer history, severe psychiatric disorders, recent weight loss drugs use, and certain cardiovascular conditions.

What is being tested?

The trial tests if semaglutide affects appetite and eating habits over time compared to a placebo. Participants also receive lifestyle advice on diet and exercise. Semaglutide is an FDA-approved medication for weight loss administered subcutaneously for 72 weeks alongside behavioral treatment.

What are the potential side effects?

Semaglutide may cause digestive issues like nausea or constipation, headaches, fatigue, risk of low blood sugar levels (hypoglycemia), potential thyroid tumors (rare), gallbladder problems like gallstones, inflammation of the pancreas (pancreatitis), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with type I or II diabetes.

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I have a serious liver or kidney condition.

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My thyroid condition is not under control.

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I have had a heart attack, stroke, heart failure, or significant heart rhythm problem in the last 6 months.

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I have had acute pancreatitis in the past 6 months.

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I have a history of chronic pancreatitis.

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I have not had cancer (other than non-melanoma skin cancer) in the last 5 years.

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I or someone in my family has had medullary thyroid cancer or MEN2.

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I have lost or gained more than 11 lbs in the last 3 months.

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I have not taken weight-altering or GLP-1 drugs in the last 6 months.

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I do not have severe depression or anxiety.

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I have not had thoughts of suicide or attempted suicide in the past year.

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I was diagnosed with bulimia nervosa in the last 5 years.

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I cannot comfortably walk 5 blocks or do similar aerobic activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ s1: change from baseline to weeks 20, 40, and 60, and measures at week 72; s2: week 72 endpoint controlling for s1 baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~s1: change from baseline to weeks 20, 40, and 60, and measures at week 72; s2: week 72 endpoint controlling for s1 baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and s1: change from baseline to weeks 20, 40, and 60, and measures at week 72; s2: week 72 endpoint controlling for s1 baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ad libitum energy intake (kcal) during a buffet lunch meal (4 hrs after standardized breakfast)

Secondary study objectives

Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version)

Global subjective appetite (e.g., hunger, fullness, food preoccupation) over the past week measured using the Control of Eating Questionnaire (COEQ)

Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task

+1 more

Other study objectives

Body image satisfaction (Body Satisfaction Scale)

Body weight (kg)

Drive for thinness (Eating Disorder Inventory [EDI])

+11 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Behavioral Treatment + PlaceboActive Control2 Interventions

Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo

Group II: Behavioral Treatment + MedicationActive Control2 Interventions

Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as Semaglutide, work by mimicking the incretin hormone GLP-1, which is released after eating. These medications enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and increase satiety, leading to reduced food intake and weight loss. For obesity patients, these mechanisms are crucial as they address both the metabolic and behavioral aspects of obesity, promoting sustained weight loss and improving overall metabolic health.